As a Senior R&D Mechanical Engineer, you will play a key role in the New Product Development group, focusing on project assignments that drive the innovation and commercialization of complex medical device assemblies. You will work with a talented cross-disciplinary team to support both new and existing products.
Key Responsibilities:
- Actively contribute to project teams by participating in activities such as design standards assessments, product design, specification preparation, device risk assessment, test method development, report preparation, and test documentation.
- Plan and schedule your activities independently to meet project timelines effectively.
- Design and coordinate standard engineering tests and experiments.
- Summarize, analyze, and draw conclusions from test results, preparing reports and documentation for the technical community.
- Collaborate closely with process development, quality, manufacturing, regulatory, clinical, and marketing teams to ensure project success.
- Develop innovative solutions for complex problems by designing tools and fixtures for current and new products.
- Exercise judgment within established practices and policies to select methods and techniques for the design of tools and fixtures.
Key Role Requirements:
- Proficient in design control documentation, including design inputs and outputs, design review, and design change management.
- Experience with mechanical design throughout the product lifecycle of medical devices.
- Familiarity with design control software tools, such as Cognition Cockpit, is highly desired.
- Commitment to patient safety and product quality, ensuring compliance with the Quality Policy and all relevant processes and procedures.
- Proficiency in Solidworks or equivalent 3D solid modeling software, and capable of producing 2D product drawings adhering to industry standards.
- Foundational understanding of Geometric Dimensioning and Tolerancing (GD&T).
- Experience in mechanical design utilizing 3D solid modeling software, with specialization in industrial product design, contemporary fabrication techniques, and design for manufacturability.
- Knowledge of mechanical design principles, including Design Failure Mode and Effects Analysis (DFMEA) and IEC 60601 Mechanical Safety Design standards.
- Desirable experience with numerical simulation using advanced design tools.
- Apply professional concepts and company policies to analyze data or situations, recommending effective solutions.
- Plan, organize, and prioritize daily work activities independently, ensuring alignment with schedules and objectives, while seeking guidance when necessary.
Minimum Qualifications:
- Hands-on experience as a design and project engineer in the regulated medical device industry, responsible for new implantable device designs, materials, equipment, and processes.
- 5+ years of work experience with a Hons bachelor’s degree in mechanical engineering or biomedical engineering.
- 3+ years of work experience with a Master’s degree in mechanical engineering or biomedical engineering.
- 1+ year(s) of work experience with a Ph.D. in Mechanical Engineering or Biomedical Engineering.
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination.